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Low-dose rectal NSAIDs for prevention of post-ERCP pancreatitis -randomized controlled multicenter study- : Loren study

Low-dose rectal NSAIDs for prevention of post-ERCP pancreatitis -randomized controlled multicenter study- : Loren study - Loren study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017106
Enrollment
500
Registered
2015-05-01
Start date
2015-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreaticobiliary disease

Interventions

May 2015-March 2019 Post-ERCP pancreatitis low risk Diclofenac non-administration May 2015-March 2019 Post-ERCP pancreatitis low risk Low dose diclofenac administration May 2015-March 2019 Post-E

Sponsors

SKY study group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The patient who needs ERCP. Possible of endoscopic approach. Normal stomach or Billroth I reconstruction stomach. Non previous EST in patients who planned biliary treatment. The patient who does not cause pancreatitis. The patient who does not use the NSAIDs within 24 hours. Main pancreatic duct < 4mm.

Exclusion criteria

Exclusion criteria: Endoscopic papillectomy. The patient who was inserted EPS or ENPD. CCr<60ml/min. Systolic blood pressure < 100mmHg before ERCP. Active peptic ulcer. Rectal ulcer or Rectal cancer. Aspirin-induced asthma. NSAIDs allergy. Triamterene oral administration. Sever cardiovascular disease. During pregnancy or lactating. Patients not to consent. ECOG Performance Status 4. The patient who admitted that it was inappropriate though the chief physician carried out the examination.

Design outcomes

Primary

MeasureTime frame
The incidence of Post-ERCP pancreatitis

Secondary

MeasureTime frame
The incidence of Hyperamylasemia The incidence of abdominal pain after ERCP Cost effectiveness

Countries

Japan

Contacts

Public ContactHirotoshi Iwano

Shibetsu City Hospital Gastroenterology

iwanohi6104@gmail.com0165-23-2166

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026